Quality Engineer

KaneHR; Walsall; On-site; GBP 30,000 - 35,000; Full time

Job summary

A leading medical technology company in the UK is seeking a Quality Engineer to work with the production team, ensuring that parts from suppliers meet design specifications and quality requirements. The engineer will handle supplier quality assessments, manage the customer return process, and support document control and corrective actions. Candidates should have experience in the medical device industry and knowledge of ISO standards. This is a full-time permanent role with a salary between £30,000 and £35,000, depending on experience.

Qualifications

• Experience of working in a medical device industry as a quality engineer is required.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience working with manufacturing/production in quality control.

Responsibilities

• Ensure suppliers meet quality standards as specified.
• Create production feedback reports for product/process issues.
• Manage the customer return process as per quality management system requirements.

Skills

Experience in the medical device industry

Knowledge of ISO 13485

Knowledge of ISO 14971

Experience in quality control

Job description

Xstrahl is an industry-leading medical technology company that develops clinical and research systems for cancer. For more than 20 years, Xstrahl has been shaping the development of superficial and orthovoltage therapies for cancer treatment and driving preclinical research. Xstrahl systems are used in more than 700 treatment and research facilities worldwide, providing complete and specialised clinical radiotherapy and research solutions for cancer and dermatology treatment.

Position Overview

As a Quality Engineer for Xstrahl this individual will work with the production team to ensure that the parts delivered from suppliers meet the design specifications and quality requirements. This engineer will help production in supplier quality assessments including creating and following up on SCARs. The Engineer will also ensure that the Device History Record (DHR) is up to date for products manufactured. The Quality Engineer will play a key role in ensuring the document control, CAPA, and complaints process is followed effectively.

Key Responsibilities

• Ensure suppliers are meeting the quality standards as specified in supplier quality agreements
• Ensure production feedback reports, NCRs, and CAPAs are created for product and process issues found in production
• Checking that all incoming parts from suppliers meeting the design specifications and quality requirements before they are accepted for production
• Create SCARs on non-confirming parts / components. Follow up with suppliers on SCARs ensuring corrective actions are effective
• Review DHRs for their completeness before authorising shipment of products
• Create production feedback reports for product or process issues found during production
• Managing the customer return process and ensuring that the returned parts are dispositioned as per the quality management system requirements
• Support the QARA team in CAPA process, document control process and complaints process

Qualifications / Experience

• Experience of working in a medical device industry as a quality engineer is required
• Working knowledge of ISO 13485 and ISO 14971
• Experience working with manufacturing / production in quality control
• Knowledge in processes for transition from EU MDD to EU MDR is a plus but not mandatory

Full-time, Permanent role

Salary will be between £30,000-£35,000, depending on experience